Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg

A Randomized, Open-label, Parallel, Multi-Center Phase IV Study to Compare of the Efficacy and Safety of Lipilou 20 mg and Lipilou 10 mg in High-risk Patients With Hypercholesterolemia(PEARL Study)

This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Lipilou®(generic atorvastatin drug) 20 mg; Drug: Lipilou®(generic atorvastatin drug) 10 mg

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Korea University Ansan Hospital
  • Bucheon, Korea, Republic of
    • Sejong General Hospital
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Goyang, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Goyang, Korea, Republic of
    • Myongji Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wŏnju, Korea, Republic of
    • Wonju Severance Christian Hospital
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.

Exclusion Criteria:

• Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
• Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group	Drug: Lipilou®(generic atorvastatin drug) 20 mg; Patients assigned to experimental group are treated with Lipilou® 20 mg
ACTIVE_COMPARATOR: Comparator group	Drug: Lipilou®(generic atorvastatin drug) 10 mg; Patients assigned to comparator group are treated with Lipilou® 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change rate in LDL-C	compare experimental group with comparator group	12 weeks of treatment

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2017
• Primary Completion (ACTUAL): May 20, 2019
• Study Completion (ACTUAL): May 20, 2019

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (ACTUAL): August 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 124HL17003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No